First, understand the filing requirements.
Before filing online sales of medical devices, it is necessary to understand the relevant requirements for filing. Including understanding the scope of application, materials required for filing, filing process, etc. This information can be obtained by consulting the official website of the Food and Drug Administration or relevant regulatory documents.
Second, prepare the filing materials
Prepare relevant filing materials according to filing requirements. These materials may include enterprise qualification certificate, medical device product registration certificate, online sales platform information, quality management system documents, etc. Ensure the authenticity and integrity of the materials, so as to successfully pass the filing review.
Third, submit the filing application.
Submit the prepared filing materials to the local food and drug supervision and administration department. The submission method can be online or offline, depending on local requirements. When submitting an application, ensure that all the contents in the application form are accurate, so as to avoid filing failure due to information errors.
Fourth, wait for the audit results.
After submitting the filing application, you need to wait for the audit results of the food and drug supervision and administration department. The audit cycle may vary from region to region and specific circumstances, so it is recommended to wait patiently. If it passes, it will obtain the online sales record certificate of medical devices; If the audit fails, it should be rectified according to the audit opinions and resubmit the application.
To sum up:
The filing of online sales of medical devices needs to be handled by the local food and drug supervision and administration department. Before handling, you need to understand the filing requirements, prepare filing materials, submit filing applications, and wait for the audit results. According to these steps, the online sales record of medical devices can be successfully completed.
Legal basis:
Measures for the supervision and administration of online sales of medical devices
Article 7 provides that:
Enterprises engaged in online sales of medical devices shall file a record with the municipal food and drug supervision and administration department located in the district in advance, and obtain the Information Form for Online Sales of Medical Devices.
Regulations on the supervision and administration of medical devices
Article 42 provides that:
When purchasing medical devices, medical device business enterprises and users shall check the supplier's qualification and medical device qualification certificate, and establish a record system for incoming inspection. Enterprises engaged in the wholesale business of Class II and Class III medical devices and the retail business of Class III medical devices shall also establish a sales record system.